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A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.

Arm/Group Title

Paricalcitol

Arm/Group Description

Open-label paricalcitol (maximum do...

Arm/Group Description

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

n=subjects with evaluable Baseline and Post-baseline data for each par...

Description

n=subjects with evaluable Baseline and Post-baseline data for each parameter.

Time Frame

Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

All-treated data set

Arm/Group Title

Paricalcitol

Arm/Group Description:

Open-label paricalcitol (maximum do...

Arm/Group Description:

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Overall Number of Participants Analyzed

13

Mean (Standard Deviation)

Unit of Measure: pg/mL

FGF-23 (n=10)

1990.7
(3317.7)

1,25-Hydroxy Vitamin D (n=11)

15.65
(29.296)

25-Hydroxy Vitamin D (n=11)

5.8
(10.38)

iPTH (n=13)

-437.5
(491.83)

15.Secondary Outcome

Title

Osteocalcin: Mean Change From Baseline to Final Visit

Description

[Not Specified]

Description

[Not Specified]

Time Frame

Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

All subjects in the all-treated data set with evaluable data

Arm/Group Title

Paricalcitol

Arm/Group Description:

Open-label paricalcitol (maximum do...

Arm/Group Description:

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Overall Number of Participants Analyzed

10

Mean (Standard Deviation)

Unit of Measure: ng/mL

117.21
(223.07)

16.Secondary Outcome

Title

Number of Subjects With Adverse Events

Description

An adverse event (AE) is defined as any untoward medical occurrence in...

Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Time Frame

From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

All-treated data set

Arm/Group Title

Paricalcitol

Arm/Group Description:

Open-label paricalcitol (maximum do...

Arm/Group Description:

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Overall Number of Participants Analyzed

13

Measure Type: Number

Unit of Measure: participants

Any TEAE

11

TESAE

2

17.Secondary Outcome

Title

Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings

Description

12-lead ECGs were recorded after the subject had been in the supine po...

Description

12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.

Time Frame

Baseline (Day 1) to Final Visit (up to Week 12)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

All-treated data set

Arm/Group Title

Paricalcitol

Arm/Group Description:

Open-label paricalcitol (maximum do...

Arm/Group Description:

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Paricalcitol

Arm/Group Description

Open-label paricalcitol (maximum do...

Arm/Group Description

Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.

All-Cause Mortality

Paricalcitol

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

Paricalcitol

Affected / at Risk (%)

Total

2/13 (15.38%)

Injury, poisoning and procedural complications

PERITONEAL DIALYSIS COMPLICATION † 1

1/13 (7.69%)

Metabolism and nutrition disorders

FLUID OVERLOAD † 1

1/13 (7.69%)

†

Indicates events were collected by systematic assessment

1

Term from vocabulary, MedDRA 17.1

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.